The drugmaker Amgen has sued Colorado’s Prescription Drug Affordability Board for a second time, alleging that the board’s decision last month to set a price ceiling on one of its medications conflicted with federal law.
The company sued last year after the board declared the arthritis drug Enbrel “unaffordable,” which ultimately allowed the state to set a maximum price that patients, pharmacies and state-regulated insurers in Colorado could pay. A federal judge threw out that case in March because Amgen hadn’t yet proven it would suffer any harm.
Enbrel treats six conditions where the immune system attacks the joints, skin or other body parts. In October, the state set roughly the same “fair price” that Medicare reached through its price negotiations, of about $31,000 per year. As of 2023, insurance companies in Colorado paid an average of about $53,000 for each patient using Enbrel, and the patients paid about $4,600.
The new lawsuit, filed in U.S. District Court in Denver on Thursday, argues that the board’s action conflicted with federal patent laws by not allowing the company to charge as much as it wants, as a reward for developing a new drug.
The initial 20-year patent on Enbrel expired in 2018, but Amgen has received more than 100 others since buying the drug from a smaller pharmaceutical company in 2002. Under those patents, generic versions won’t hit the U.S. market until 2029.
“Congress struck a deliberate balance in the pharmaceutical arena — allowing those who develop innovative new drugs, and who can be expected to invest in new innovations, to benefit from market exclusivity for a specific and defined period while encouraging price competition thereafter,” the complaint said.
The lawsuit also alleged the board’s procedure violated drugmakers’ due process rights and unconstitutionally regulates transactions happening outside Colorado. While the upper payment limit only applies to patients and companies within the state, it would put downward pressure on prices that middlemen pay to Amgen for doses that ultimately will go to Colorado residents.
A spokesman for the Colorado Attorney General’s Office declined to comment on pending litigation.
Colorado is the first state to put a price ceiling on a prescription drug, and the consequences are unknown.
The law creating the board requires drugmakers pulling out of Colorado to give at least six months’ notice or pay a $500,000 fine. Amgen hasn’t said if it would consider such a step, though it has issued statements that the price limit could interfere with the drug’s availability.
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